MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAV THORACIC PROBE TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734680
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available from the site.The thoracic probe 9734680 navlock (171004) was returned for analysis.Analysis found that the tip of the returned probe was bent and slightly twisted.There were also impact marks at the back end of the probe.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used intra-operatively of a sacroiliac and thoracolumbar procedure.It was reported that there was a damaged navlock and thoracic probe.The thoracic probe was stuck in the orange navlock.It was unclear which instrument was damaged and causing the issue.The wings would not release.It had been determined that the thoracic probe and orange navlock could not be separated easily by the personnel.There was no delay to the procedure and no impact on the patient outcome.

• Brand Name: NAV THORACIC PROBE TIP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9447724
• Report Number: 1723170-2019-05947
• Device Sequence Number: 470097
• Product Code: OLO
• UDI-Device Identifier: 00613994870063
• UDI-Public: 00613994870063
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 171004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR